Methods for the Endoluminal Treatment of Gastroesophageal Reflux Disease (GERD)

ABSTRACT

A medical method includes sliding two substantially straight unconnected arms over a fold of body tissue such that a first arm contacts a first portion of the fold and a second arm contacts a second portion. Then, each arm is bent completely through the fold such that both of the arms compress the portions of the fold into contact with each other. Another method includes releasably coupling first and second substantially linear arms to a bridge, each of the arms having a substantially straight sliding portion and a bendable piercing portion. The arms are slid over opposing sides of two body tissue layers, the first arm sliding over the first layer and the second over the second layer. While the sliding portions of the arms remain substantially straight, each piercing portion is bent completely through the adjacent layer and halfway through the other layer to compress the two layers together.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is:

-   -   a divisional of sister U.S. patent application Ser. Nos.        10/010,244, 10/010,246, and 10/010,247 (now U.S. Pat. No.        7,232,445), all filed Dec. 6, 2001 (which applications are        continuations-in-part of U.S. Pat. No. 6,569,085, filed Aug. 16,        2001, of U.S. Pat. No. 6,716,226, filed Jun. 25, 2001, and of        U.S. Pat. No. 6,551,315, filed Dec. 6, 2000);    -   related to co-owned U.S. Pat. Nos. 6,843,794 (Ser. No.        10/010,903), 6,743,240 (Ser. No. 10/010,904), 6,824,548 (Ser.        No. 10/010,906), 7,070,602 (Ser. No. 10/010,908), and 6,945,979        (Ser. No. 10/010,912), all filed Dec. 6, 2001, and U.S. patent        application Ser. No. 10/151,529, filed May 20, 2002; and    -   a sister divisional to U.S. patent application Ser. No.        11/636,341 filed Dec. 7, 2006,        the complete disclosures of which are hereby incorporated by        reference herein in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to endoscopic surgical procedures. Moreparticularly, the invention relates to procedures for the transoralinvagination and fundoplication of the stomach to the esophagus.

2. State of the Art

Gastroesophageal fundoplication is a procedure for the treatment ofgastroesophageal reflux disease (GERD), a condition in which gastricacids are regurgitated into the esophagus resulting in one or more ofesophagitis, intractable vomiting, asthma, and aspiration pneumonia. Thefundoplication procedure involves wrapping the fundus of the stomacharound the lower end of the esophagus and fastening it in place.Traditionally, this procedure is accomplished via open surgery with theuse of sutures to secure the plicated fundus of the stomach around theesophagus without penetrating (incising) the stomach. Althoughtraditional fundoplication involves plicating the fundus and theesophagus, as used herein the term includes plicating the fundus toitself near the esophagus.

U.S. Pat. No. 5,403,326 to Harrison et al. discloses a method ofperforming endoscopic fundoplication using surgical staples or two-partsurgical fasteners. The procedure disclosed by Harrison et al. involvesperforming two percutaneous endoscopic gastrotomies (incisions throughthe skin into the stomach) and the installation of two ports throughwhich a stapler, an endoscope, and an esophageal manipulator(invagination device) are inserted. Under view of the endoscope, theesophageal manipulator is used to pull the interior of the esophagusinto the stomach. When the esophagus is in position, with the fundus ofthe stomach plicated, the stapler is moved into position around thelower end of the esophagus and the plicated fundus is stapled to theesophagus. The process is repeated at different axial and rotarypositions until the desired fundoplication is achieved. While, theprocedure disclosed by Harrison et al. is a vast improvement over opensurgery, it is still relatively invasive requiring two incisions throughthe stomach.

U.S. Pat. No. 5,571,116 to Bolanos et al. discloses a non-invasivetreatment of gastroesophageal reflux disease which utilizes a remotelyoperable invagination device and a remotely operable surgical stapler,both of which are inserted transorally through the esophagus. Accordingto the methods disclosed by Bolanos et al., the invagination device isinserted first and is used to clamp the gastroesophageal junction. Thedevice is then moved distally, pulling the clamped gastroesophagealjunction into the stomach, thereby invaginating the junction andinvoluting the surrounding fundic wall. The stapler is then insertedtransorally and delivered to the invaginated junction where it is usedto staple the fundic wall.

Bolanos et al. disclose several different invagination devices andseveral different staplers. Generally, each of the staplers disclosed byBolanos et al. has an elongate body and a spring biased anvil which isrotatable approximately 15 degrees away from the body in order to locatethe invaginated gastroesophageal junction between the body and theanvil. The body contains a staple cartridge holding a plurality ofstaples, and a staple firing knife. Each of the invagination devicesdisclosed by Bolanos et al. has a jaw member which is rotatable at least45 degrees and in some cases more than 90 degrees to an open positionfor grasping the gastroesophageal junction. One of the chiefdisadvantages of the methods and apparatus disclosed by Bolanos et al.is that the stapler and the invagination device must both be present inthe esophagus at the same time. With some of the embodiments disclosed,the presence of both instruments is significantly challenged by the sizeof the esophagus. In addition, the actuating mechanism of the devicedisclosed by Bolanos et al. is awkward. In particular, the stapler anvilis biased to the open position, and it is not clear whether or not thestapler anvil can be locked in a closed position without continuouslyholding down a lever. In addition, it appears that the staple firingtrigger can be inadvertently operated before the anvil is in the closedposition. This would result in inadvertent ejection of staples into thestomach or the esophagus of the patient.

U.S. Pat. No. 6,086,600 to Kortenbach discloses an endoscopic surgicalinstrument including a flexible tube, a grasping and fastening endeffector coupled to the distal end of the tube, and a manual actuatorcoupled to the proximal end of the tube. The manual actuator is coupledto the end effector by a plurality of flexible cables which extendthrough the tube. The tube contains a lumen for receiving a manipulableendoscope and the end effector includes a passage for the distal end ofthe endoscope. The end effector has a store for a plurality of malefastener parts, a store for a plurality of female fastener parts, arotatable grasper, a rotatable fastener head for aligning a femalefastener part and a male fastener part with tissues therebetween, and afiring member for pressing a male fastener part through tissues graspedby the grasper and into a female fastener part. According to a statedpreferred embodiment, the overall diameters of the flexible tube and theend effector (when rotated to the open position) do not exceedapproximately 20 mm so that the instrument may be delivered transorallyto the fundus of the stomach.

While transoral invagination and fundoplication apparatus and procedureshave improved over the years, it is still difficult to deliver andmanipulate the necessary apparatus transorally. The primary reason forthe difficulty is that the overall diameter, or more accurately thecross sectional area, of the equipment is too large. NotwithstandingKortenbach's reference to 20 mm, most of the equipment in use today isat least 24 mm in diameter. Moreover, even if the equipment could bereduced to 20 mm in diameter (314 mm2 cross sectional area), it wouldstill be difficult to manipulate. Those skilled in the art willappreciate that larger instruments are less pliable and that theinvagination and fundoplication procedure requires that the instrumentsturn nearly 180 degrees. Moreover, it will be appreciated that largeinstruments obscure the endoscopic view of the surgical site.

Still other issues which need to be addressed in this procedure includethe need to suitably grasp the fundus before plication so that alllayers of the fundus are plicated. Preferably, plication damages thefundus so that adhesion occurs during healing.

3. Co-Owned Technology

Previously incorporated application Ser. No. 09/730,911, filed Dec. 6,2000, entitled “Methods and Apparatus for the Treatment of GastricUlcers”, discloses a surgical tool which is delivered to a surgical siteover an endoscope rather than through the working lumen of an endoscope.

Co-owned provisional application Ser. No. 60/292,419, filed May 21,2001, entitled “Methods and Apparatus for On-Endoscope InstrumentsHaving End Effectors and Combinations of On-Endoscope andThrough-Endoscope Instruments”, discloses many tools and proceduresincluding an on-scope grasper assembly having grasping jaws, and athrough-scope clip applier having jaws adapted to close about tissue andapply a clip over and/or through the tissue. In operation, the grasperjaws may grab and hold tissue, e.g., the fundus of the stomach oresophageal tissue, while the jaws of the clip applier surround a portionof the tissue held by the grasper jaws and apply a clip thereover.

Previously incorporated application Ser. No. 09/891,775, filed Jun. 25,2001, entitled “Surgical Clip”, discloses a surgical clip having aU-shaped configuration with first and second arms, and a bridge portiontherebetween. The first arm is provided with a tip preferably having acatch, and the second arm extends into a deformable retainer having atissue-piercing end and preferably also a hook. During application,tissue is clamped, and the clip is forced over the clamped tissue andthe retainer of the second arm is bent and may be pierced through thetissue. The retainer is toward and around or adjacent the tip of thefirst arm preferably until the hook is engaged about the catch to securethe clip to the tissue and prevent the clip and tissue from separating.The clip is provided with structure that facilitates the stacking of aplurality of clips in a clip chamber of a clip applier.

Previously incorporated application Ser. No. 09/931,528, filed Aug. 16,2001, entitled “Methods and Apparatus for Delivering a MedicalInstrument Over an Endoscope while the Endoscope is in a Body Lumen”,discloses methods and apparatus for delivering a medical instrument overthe exterior of an endoscope while the endoscope is installed in thepatient's body in order to allow the use of instruments which are toolarge to fit through the lumina of an endoscope.

The previously incorporated simultaneously filed application entitled“Flexible Surgical Clip Applier”, discloses a surgical clip applierhaving a pair of clip applying jaws at the distal end of an outer coil,a set of pull wires extending through the outer coil and coupled to thejaws, and a push wire extending through the outer coil. A clip chamberis provided in the distal end of the coil. A clip pusher is provided ata distal end of the push wire, and adapted to advance a clip into thejaws. The jaws include clamping surfaces which operate to compresstissue between the jaws when the jaws are closed, channels in which adistal most clip rides when the jaws are closed and the pusher isadvanced thereby causing the distal most clip to be pushed over thetissue, and distal anvil portions which operate to bend a portion of thedistal most clip to facilitate its retention on the clamped tissue. Theclip applier is capable of providing a pushing force far in excess of aperceived possible maximum of the 200 grams (0.44 lbs) published in theart. One embodiment of the device of the invention provides a pushingforce in excess of 2267 grams (5 lbs).

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide methods andapparatus for transoral invagination and fundoplication.

It is also an object of the invention to provide an apparatus fortransoral invagination and fundoplication which is easy to manipulate.

It is another object of the invention to provide an apparatus fortransoral invagination and fundoplication which has a relatively smallcross-sectional area.

It is still another object of the invention to provide methods andapparatus for fundoplication which combine the relative advantages ofstaples and two-part fasteners, i.e. the small size of a staple and thegreater integrity of a two-part fastener.

It is yet another object of the invention to provide methods andapparatus for transoral invagination and fundoplication which damagestissue such that adhesion occurs during healing.

In accord with these objects which will be discussed in detail below,the methods of the invention include delivering a grasper, a clipapplier, and an endoscope transorally to the site of fundoplication;grasping the fundus with the grasper (or similar device, e.g. corkscrew)and pulling it into the jaws of the clip applier; closing the jaws ofthe clip applier over the fundus and applying a clip to the fundus. Themethod is repeated at different locations until the desiredfundoplication is achieved. The apparatus of the invention includes aclip applier having sharp toothed jaws for grasping and damaging thefundus prior to applying the clip. The clip applier has an overalldiameter of less than 7 mm and may be delivered through a 7 mm sleevewhich attaches to a 12 mm endoscope having a lumen through which thegrasper is delivered. The overall cross-sectional area of the apparatusis therefore approximately 152 mm2 as compared to the 314 mm2 of theprior art devices. Alternatively, the clip applier and the grasper maybe delivered through an endoscope having two 6 mm lumina.

According to a presently preferred embodiment, the clip applier jaws arecoupled to a pull wire via a linkage which increases the mechanicaladvantage and thus permits greater grasping force.

A plurality of clip designs is provided. Some embodiments include a pairof arms coupled by a bridge and a single locking retainer. Otherembodiments include dual parallel coiled retainers. According to oneembodiment, the clip has two detachable retainers which are installed inthe fundus and the clip arms and bridge are removed.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a clip applier according to theinvention;

FIG. 2 is a side elevational view of a first embodiment of the distalend of the clip applier with the jaws in the closed position;

FIG. 3 is a side elevational view of a first embodiment of the distalend of the clip applier with the jaws in the open position;

FIG. 4 is a broken isometric view of a first embodiment of the distalend of the clip applier with one jaw removed;

FIG. 5 is a broken isometric view of a second embodiment of the distalend of the clip applier with a clip of the type shown in FIGS. 19 and20;

FIG. 6 is an isometric view of a single jaw of the second embodiment ofthe distal end of the clip applier;

FIG. 7 is a proximal end view of the jaw of FIG. 6;

FIG. 8 is a proximal end view of the two jaws of a second embodiment ofthe distal end of the clip applier in the closed position with the lowerjaw shaded for clarity;

FIG. 9 is a broken isometric view of a third embodiment of the distalend of the clip applier suitable for use with a clip of the type shownin FIGS. 17 and 18 or 24;

FIGS. 10 to 14 are schematic views illustrating a method according tothe invention;

FIG. 15 is a diagram illustrating the comparative cross-section of theinstruments used in the method illustrated in FIGS. 5 to 10 and atypical prior art instrument;

FIG. 16 is a cross-sectional view of a dual lumen endoscope which can beused in performing the methods of the invention;

FIG. 17 is a side elevational view of a first embodiment of a clipaccording to the invention prior to application;

FIG. 18 is a side elevational view of the clip of FIG. 17 afterapplication;

FIG. 19 is a side elevational view of a second embodiment of a clipaccording to the invention prior to application;

FIG. 20 is a side elevational view of the clip of FIG. 19 afterapplication;

FIG. 21 is a side elevational view of a third embodiment of a clipaccording to the invention prior to assembly;

FIG. 22 is a side elevational view of the clip of FIG. 21 assembledprior to application;

FIG. 23 is a side elevational view of the applied portion of the clip ofFIGS. 17 and 18;

FIG. 24 is a view similar to FIG. 23 of an alternate third embodiment ofthe applied portion of a clip according to the invention; and

FIG. 25 is a fragmentary, cross-sectional enlarged view of a portion ofthe clip applier of FIG. 5 with a portion of a clip in an applier grooveand through tissue.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, a clip applier 10 according to the inventiongenerally includes a flexible wound outer coil 12 having a proximal end14 and a distal end 16. An end effector assembly 18 is coupled to thedistal end 16 of the coil 12 and an actuator assembly 20 is coupled tothe proximal end 14 of the coil 12. A plurality of pull/push wires 58,60 (shown and described below with reference to FIGS. 2-4) extendthrough the coil 12 and couple the end effector assembly 18 to theactuator assembly 20. The clip applier 10 is similar to the clip applierdescribed in detail in previously incorporated co-owned application Ser.No. 10/010,908, entitled “Flexible Surgical Clip Applier”, filedsimultaneously herewith. However, in this application, the end effectorassembly 18 is designed specifically for fundoplication using a clipsignificantly larger than that used in the clip applier of the aforesaidco-owned application.

FIGS. 2-4 illustrate the details of the end effector assembly 18according to a first embodiment of the invention. The end effectorassembly 18 includes a pair of jaws 22, 24 which are rotatably coupledto a clevis 26. In particular, the clevis 26 has a central channel 28(seen best in FIG. 4) which is defined by clevis arms 30, 32. Althoughthe term “clevis” is used because of its general acceptance in the artof endoscopic instruments, the “clevis” 26 is preferably covered on topand bottom so that the only exit from the channel 28 is at the distalend. The jaw 22 is rotatably coupled to the clevis arm 30 by an axle 34and the jaw 24 is rotatably coupled to the clevis arm 32 by an axle 36.The axles 34 and 36 are dimensioned such that they do not significantlyobscure the channel 28.

The jaws 22, 24 are substantially identical. Each jaw 22, 24 includes aproximal tang 38, 40, a mounting bore 42, 44, a distal hook shaped anvil46, 48 and a plurality of medial teeth 50, 52. As seen best in FIG. 4,the medial teeth 50, 52 are arranged on one side of the jaw and a shortwall 51, 53 is arranged on the opposite side of the jaw to define agroove (or guiding channel) 54, 56. The grooves 54, 56 meet the anvils46, 48 each of which has a helical surface. The interior (proximal)helical surfaces of the anvils act to bend the clip retainers asdescribed below with reference to FIGS. 19-24.

The proximal tang 38, 40 of each jaw is coupled to a respectivepull/push wire 58, 60 via two links 62, 64 and 66, 68. The links 62, 66are substantially L-shaped and are rotatably coupled near their elbow tothe clevis arms 30, 32 by axles 70, 72 which do not significantlyobscure the channel 28 between the clevis arms. One end of the link 62,66 is coupled to the pull/push wire 58, 60 and the other end of the link62, 66 is rotatably coupled to one end of the link 64, 68. The other endof the link 64, 68 is rotatably coupled to the tang 38, 40. The combinedcoupling of each jaw 22, 24 to each pull/push wire 58, 60 forms alinkage which amplifies the force from the pull/push wires to the jaws.In particular, as the jaws close, the mechanical advantage increases.

The proximal ends of the pull/push wires 58, 60 are coupled to theactuator assembly (20 in FIG. 1) as described in previously incorporatedco-owned application Ser. No. 10/010,908, entitled “Flexible SurgicalClip Applier”, filed simultaneously herewith.

A clip pusher (not shown) disposed in the interior of the coil iscoupled to a push wire (not shown) which is coupled to the actuatorassembly as described in previously incorporated co-owned applicationSer. No. 10/010,908, entitled “Flexible Surgical Clip Applier”, filedsimultaneously herewith. Unlike the previously incorporated co-ownedapplication, the jaws of the instant clip applier are significantlylonger and designed for use with clips approximately 17-20 mm long(after the clip is applied) as compared to the 5-7 mm clips shown in thepreviously incorporated co-owned application.

Turning now to FIGS. 5-8, a second embodiment of the jaws 22′, 24′ isillustrated. The jaws 22′, 24′ are substantially identical to each otherand are designed for use with any of the clips illustrated in FIGS.19-24. Each jaw 22′, 24′ includes a proximal tang 38′, 40′, a mountingbore 42′, 44′, a distal hook shaped anvil 46′, 48′ and a plurality ofmedial teeth 50′, 52′. The medial teeth 50′, 52′ are arranged on oneside of the jaw and a short wall 51′, 53′ is arranged on the oppositeside of the jaw to define a groove (or guiding channel) 54′, 56′. Thegrooves 54′, 56′ meet the interior surfaces of the anvils 46′, 48′ whichcurve about a single axis. The interior surfaces of the anvils act tobend the clip retainers as described below with reference to FIGS. 19-24and as shown by the clip 310 in FIG. 5. According to this embodiment, asseen best in FIGS. 6-8, the guiding channels 54′, 56′ and the anvils46′, 48′ are angled relative to the vertical axis of the jaw 22′, 24′.This angle causes the clip to twist as it is pushed through the jaws sothat the ends of the clip are offset as shown in FIG. 5, for example.According to the presently preferred embodiment, the guiding channels54′, 56′ and the anvils 46′, 48′ are angled approximately 22° relativeto the vertical axis of the jaw 22′, 24′. According to a method of theinvention, clips for use with this embodiment of the jaws are pre-bentin the bridge area to facilitate movement through the angled channels.

FIG. 25 illustrates an enlarged portion of the clip applier of FIG. 5showing that the clip 310 rests inside an applier groove 54′, 56′ and isbent by the anvil 48′ as it pierces a folded over portion of body tissue500.

Referring now to FIG. 9, a third embodiment of the jaws 22″, 24″ isillustrated. The jaws 22″, 24″ are not identical to each other and aredesigned for use with clips of the type illustrated in FIGS. 17-18. Eachjaw 22″, 24″ includes a proximal tang 38″, 40″ and a mounting bore 42″,44″. One jaw 22″ terminates with two spaced apart distal hooks 46″, 47″and has two rows of medial teeth 50″. The other jaw 24″ terminates witha single distal hook shaped anvil 48″ and has two rows of medial teeth52″. The medial teeth 50″, 52″ are arranged on both sides of the jaw anda groove (or guiding channel) 54″, 56″ lies between the rows of teeth.The groove 54″ terminates with an undercut well (not shown) as describedin co-owned Ser. No. 10/010,908, whereas the groove 56″ continues on tothe interior of the anvil 48″ which has a surface which curves about asingle axis. Those skilled in the art will appreciate that when the jawsare closed, the anvil 48″ will reside between the hooks 46″ and 47″ andthe teeth 50″ will be interleaved with the teeth 52″. The interiorsurface of the anvil 48″ bends the clip retainer as described below withreference to FIGS. 17-18 and as shown and described in previouslyincorporated co-owned application Ser. No. 09/891,775, and Ser. No.10/010,908.

Turning now to FIGS. 10-14, a method of using the clip applier of theinvention is illustrated in context with an existing endoscope 100having a single lumen through which a small grasper 102 is supplied andan external working channel 104 which is attached to the scope 100 andthrough which the clip applier is delivered; The external workingchannel 104 is preferably one of the type described in previouslyincorporated application Ser. No. 09/931,528, filed Aug. 16, 2001,entitled “Methods and Apparatus for Delivering a Medical Instrument Overan Endoscope while the Endoscope is in a Body Lumen”.

According to a method of the invention, after the endoscope assembly isdelivered transorally to the procedural site, as shown in FIG. 10, thefundus is grasped by the graspers and pulled in between the open jaws ofthe clip applier. The jaws of the clip applier are then closed onto theinvaginated fundus as shown in FIG. 11. As the jaws are closed themedial teeth of the jaws puncture the invaginated fundus as shown inFIGS. 11 and 12. When the jaws are completely closed (or closed as muchas possible), they are preferably locked, the grasper is optionallyreleased, and the clip pusher is activated to push forward, advance,and/or slide, with or without tissue contact, a clip 106 as shown inFIG. 12 and as described in the previously incorporated, co-owned,simultaneously filed application and discussed in detail hereinafter.

After the clip 106 is applied, the jaws of the clip applier are openedas shown in FIG. 13 and the clip 106 remains in place and plicates thefundus. Depending on the location of the clip and the nature of thepatient's condition, a single clip may be sufficient. If other clips aredeemed desirable by the practitioner, the clip applier is removed andre-loaded with another clip. After re-delivering the clip applier, theprocedure may be repeated at another location as shown in FIG. 14. Giventhe size of the clips of the invention, anywhere from 1-4 clips willtypically be used.

According to one aspect of the invention, the medial teeth on the jawsof the clip applier are long enough and sharp enough to damage thefundus sufficiently such that when the fundus heals adhesion occurs,binding the plicated fundus to the extent that the clip may no longer beneeded. Thus, preferably, the teeth are long enough to pierce all layersof the fundus.

From the foregoing, those skilled in the art will appreciate that themethods of the invention may be performed with different types ofgraspers. In particular, alternative grasping devices such as a “corkscrew” grasper can be used in conjunction with the clip applier of theinvention to perform the methods of the invention.

It will also be appreciated that the clip applier of the invention maybe attached to an endoscope in other ways as described in previouslyincorporated application Ser. No. 09/931,528, filed Aug. 16, 2001,entitled “Methods and Apparatus for Delivering a Medical Instrument Overan Endoscope while the Endoscope is in a Body Lumen”.

As mentioned above, the clip applier of the invention has an outsidediameter of approximately 6 mm. As shown in FIGS. 10-14, the clipapplier is used in conjunction with an endoscope having an outsidediameter of approximately 12 mm. To accommodate the clip applier, anexterior working channel having an exterior diameter of approximately 7mm is optionally coupled to the endoscope as described in the previouslyincorporated co-owned application Ser. Nos. 09/931,528 and 60/292,419.

FIG. 15 is a scale representation of the cross-sectional area of the 12mm endoscope 100 with the attached external 7 mm working channel 104,shown in horizontal shading. The cross sectional area of a prior artdevice 108 having an exterior diameter of approximately 24 mm is shownin diagonal shading. From FIG. 15, it will be appreciated that themethods and apparatus of the invention allow for a substantially smallerdevice which is more easily delivered transorally and which is moreeasily manipulated. The overall cross-sectional area of the apparatus ofthe invention is approximately 152 mm2 as compared to the 314 mm2 of theprior art devices.

As mentioned, the clip applier of the invention may also be used with adual lumen endoscope. FIG. 16 is a scale representation of a dual lumenendoscope 110 having an optical lumen 112 and two 6 mm working lumina114, 116. As compared to the device 108 in FIG. 15, the endoscope 110has a substantially smaller cross-sectional area than the prior artdevice.

The clips used by the clip applier of the invention are substantiallylonger than the clips described in the previously incorporated co-ownedapplication Ser. No. 09/891,775 and the simultaneously filedapplication, which are approximately 7 mm in length and adequate forgeneral surgical applications. The retainer portion of the clips of thepresent invention is substantially longer in order to assure that all ofthe layers of the fundus are punctured.

Turning now to FIGS. 17 and 18, a first embodiment of a surgical clip210 according to the invention includes first and second arms 212, 214,respectively, and a bridge portion 216 therebetween such that the armsand bridge portion are in a generally U-shaped configuration. The firstarm 12 is provided with an end catch 220, and the second arm 214 extends(or transitions) into a deformable retainer 222 having a tissue piercingtip 224 and a plurality of catch engagements, e.g. 226, 228. The armsdefine an open space 230 between them. The clip 210 is preferably madefrom a unitary piece of titanium, titanium alloy, stainless steel,tantalum, platinum, other high Z (substantially radiopaque) materials,nickel-titanium alloy, martensitic alloy, or plastic, although othersuitable biocompatible materials may be used. The first and second arms212, 214, as well as the bridge portion 216 are relatively stiff and notplastically deformable within the limits of force applied to the armsduring use, while the retainer 222 is relatively easily plasticallydeformable by the clip applier.

Referring now to FIGS. 2-4 and 17-18, when the clip 210 is pushedforward in the clip applier with the jaws 22, 24 of the clip applierclosed, the retainer 222 is bent across the opening 230 between thefirst and second arms 212, 214 and into engagement with the end catch220 of the first arm 212 as shown in FIG. 18. The anvil formed by thegrooves on the interior of the hooks 46, 48 of the clip applier jawsguide the bending of the retainer 222 causing it to puncture the fundusand couple to the end catch 220.

The clip 210 shown in FIGS. 17 and 18 is provided with an optionalbendable barb 232 which provides a secondary stabilizing fixation pointwhich helps keep the clip from rotating. As the clip is pushed forwardover the fundus, tissue catches the barb 232 and bends it as shown inFIG. 18.

The clip 210 is also provided with an ear 233 on the bridge 216. The earis used by the pushing mechanism (not shown) to grasp the end of theclip when it is loaded into the clip applier.

A second embodiment of a clip 310 according to the invention is shown inFIGS. 19 and 20. The clip 310 has two arms 312, 314 connected by abridge 316. Both arms terminate in retainers 320, 322, each having asharp end 321, 323. The clip 310 is also provided with a pair of ears333, 335 on the bridge 316. The ears are used by the pushing mechanism(not shown) to grasp the end of the clip when it is loaded into the clipapplier. This embodiment is intended for use with a clip applier havinghooks with interior grooves which diverge, or which are in parallelplanes. With reference to FIGS. 2-4 and 15-16, when the clip 310 ispushed forward, the retainer 320 is bent by the groove inside the hook46 and the retainer 322 is bent by the groove inside the hook 48 to theconfiguration shown in FIG. 20. From FIG. 20, it will be appreciatedthat each retainer punctures the fundus twice substantially forming acircular fastener. Thus, it will also be appreciated that the retainers320, 322 are significantly longer than the retainer 222 shown in FIGS.17 and 18 and preferably are of a length at least p times the distancebetween the arms 312, 314. Insofar as the retainers 320, 322 each form acomplete fastener, the function of the arms 312, 314 and the bridge 316may be considered redundant.

FIGS. 21-23 illustrate a third embodiment of a clip 410 according to theinvention. The clip 410 is similar to the clip 310 (with similarreference numerals increased by 100 referring to similar parts) exceptthat the retainers 420, 422 are removable from the arms 412, 414. Thearms 412, 414 terminate in female couplings 413, 415 which receive endsof the retainers 420, 422 in a slight interference fit. The clip 410 isalso provided with a pair of ears 433, 435 on the bridge 416. The earsare used by the pushing mechanism (not shown) to grasp the end of theclip when it is loaded into the clip applier. The clip 410 is applied tothe fundus in substantially the same way as described above withreference to the clip 310. However, after the retainers 420, 422 arebent by the anvils and the jaws are opened, the clip 410 is not releasedfrom the clip applier and the retainers are separated from the arms 412,414. The resulting fastener formed by the retainers 420, 422 is shown inFIG. 23. This is actually two substantially parallel “b” shapedfasteners. Thus, it may only be necessary to apply a single retainer asshown in FIG. 24, for example.

There have been described and illustrated herein several embodiments ofmethods and apparatus for the endoluminal treatment of gastroesophagealreflux disease. While particular embodiments of the invention have beendescribed, it is not intended that the invention be limited thereto, asit is intended that the invention be as broad in scope as the art willallow and that the specification be read likewise. It will therefore beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as so claimed.

1. A medical method, comprising: inserting an endoscope transorallythrough the esophagus to the stomach; inserting a grasping devicetransorally through the esophagus to the stomach; inserting a surgicalclip applier having at least one clip transorally through the esophagusto the stomach; invaginating the fundus of the stomach with the graspingdevice; and using the clip applier to first slide the clip over theinvaginated fundus and then to apply force to bend at least one end ofthe clip to pass through the invaginated fundus in order to plicate thefundus.
 2. The method according to claim 1, wherein: the step ofinserting a grasping device comprises inserting the grasping devicethrough a lumen of the endoscope.
 3. The method according to claim 2,which further comprises: attaching a sheath to an exterior of theendoscope; and the step of inserting a surgical clip applier comprisesinserting the clip applier through the sheath.
 4. The method accordingto claim 1, wherein: the step of inserting a surgical clip appliercomprises attaching the clip applier to the exterior of the endoscopeprior to said inserting the endoscope.
 5. The method according to claim2, wherein: the step of inserting a surgical clip applier includesinserting the clip applier through a second lumen of the endoscope. 6.The method according to claim 2, which further comprises: attaching aguide to an exterior of the endoscope; and the step of inserting asurgical clip applier comprises attaching the clip applier to the guide.7. The method according to claim 1, wherein: the step of inserting asurgical clip applier comprises attaching the clip applier to theexterior of the endoscope after said inserting the endoscope.